PMA P150021S036
- Device
- Flash Glucose Monitoring System
- Applicant
- Abbott Diabetes Care, Inc.
- PMA number
- P150021
- Supplement
- S036
- Product code
- MDS
- Decision date
- 2019-04-05
- Classification
- Sensor, Glucose, Invasive
- Generic name
- Sensor, glucose, invasive
- Approval order statement
- Approval for the implementation of individual sensor calibration (ISC) and incorporation of the ISC methodology in the performance monitoring sampling process
Current openFDA PMA Record#
- Device
- Flash Glucose Monitoring System
- Applicant
- Abbott Diabetes Care, Inc.
- PMA number
- P150021
- Supplement
- S036
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2019-04-05
- Decision code
- APPR
- Date received
- 2018-10-31
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the implementation of individual sensor calibration (ISC) and incorporation of the ISC methodology in the performance monitoring sampling process